The Use of Drug Master Files & Quality Agreements

  • Check with publisher
  • Published date: July 17, 2020
    • Fremont, California, United States

This combined DMF (Drug Master Files) and Quality Agreement training will discuss the advantages for suppliers and drug product manufacturers in developing these arrangements together.

Over time, there have been several misunderstandings between supplier / contractors and pharmaceutical / biologic finished product manufacturers. The root of many of the problems lie in a lack of a suitable agreement delineating roles, responsibilities and resolution to agreement to these issues. Part of these arrangements typically involve the development, support and updating of confidential technical files (Drug Master files), which allow suppliers to protect their confidential product and process information from each and every customer and share it only with the Agency.

The course will include the current review and enforcement climate within FDA and the manner, in which Drug Master Files (DMFs) are reviewed by FDA personnel. Besides the US, the use of DMFs in the EU, Japan, Canada and Australia will also be discussed. Similarities and differences to the U.S. system will be highlighted.

https://www.gcplearning.com/virtual-seminar/6-hour-virtual-seminar-on-the-use-of-drug-master-files-&-quality-agreements:-understanding-and-meeting-your-regulatory-and-processing-responsibilities-11493LIVE

John Robinson
0 votes

Useful information

  • Avoid scams by acting locally or paying with PayPal
  • Never pay with Western Union, Moneygram or other anonymous payment services
  • Don't buy or sell outside of your country. Don't accept cashier cheques from outside your country
  • This site is never involved in any transaction, and does not handle payments, shipping, guarantee transactions, provide escrow services, or offer "buyer protection" or "seller certification"

Related listings

  • Moving From An Operational Manager to A Strategic Leader

    Moving From An Operational Manager to A Strategic Leader

    Clinical/Medical Sciences Fremont (California) July 17, 2020 Check with publisher

    Gain the insights and skills to know where your business stands today and where it’s heading tomorrow. In today’s unpredictable business environment, strategic leadership is not just for top management alone. It’s for: Managers who may be managing th...

  • Controlling Human Error in the Manufacturing Floor

    Controlling Human Error in the Manufacturing Floor

    Clinical/Medical Sciences Fremont (California) July 17, 2020 Check with publisher

    Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design sta...

  • 6-Hour Virtual Seminar on The DHF, DMR, DHR, EU MDR Technical Documentation

    6-Hour Virtual Seminar on The DHF, DMR, DHR, EU MDR Technical Documentation

    Clinical/Medical Sciences Fremont (California) July 17, 2020 Check with publisher

    One of our most popular seminars, continuously updated with the latest U.S. FDA and Eurpean Union requirements. Now expanded to a six-hour format. As U.S. companies go global, they must meet different product design documentation. The cGMPs mandate D...